3 — Class II medical device recall Z-1710-2016
Terminated recall by Synthes (USA) Products LLC, reported 2016-06-01, distributed nationwide. The sterile packaging may be compromised. A protective cap is to be secured on the tip of the drill bit. If th
| Recall number | Z-1710-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes (USA) Products LLC, West Chester, PA, United States |
| Recall initiated | 2016-04-18 |
| Classified | 2016-05-23 |
| Reported by FDA | 2016-06-01 |
| Terminated | 2017-02-02 |
| Distributed | Nationwide (US) |
| Quantity | 1,274 units |
| Reason classes | sterility |
| Lot numbers | 5525872, 5548707, 5575918, 5603463, 5649117, 5668880, 5724639, 5742276, 5807341, 6012770, 6045597, 6057914, 6108342, 6142443, 6153368, 6197315, 6199232, 6231850, 6256560, 6305842, 6319050, 6320150, 6343980, 6401819, 6448707, 6472100, 6501856, 6503351, 6530901, 6581051, 6676406, 6721724, 6734876, 6808463, 6831468, 6997294, 7039877, 7052565, 7081479, 7378832 and 13 more |
| Model numbers | 03.010.060S, 03.010.100S |
Product
3.2 mm three-fluted Radiolucent Drill Bit/Needle Point/145 mm Sterile Product Usage: The 3.2 mm Three-fluted Drill Bits are instruments that can be used with the following systems: Expert Lateral Femoral Nail (part number 03.010.060S only), Expert Tibial Nail, Expert Humeral Nailing, Multiloc Humeral Nailing System, Suprapatellar Instrumentation for Expert Tibial Nail, and Adolescent Lateral Femoral Nails (ALFN).
Reason for recall
The sterile packaging may be compromised. A protective cap is to be secured on the tip of the drill bit. If the protective cap is not secured, the drill bit may puncture the sterile barrier.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1710-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.